1. Field of the Invention
The present invention relates generally to medical devices and methods. In particular, the present invention relates to a method and a system for sizing an oral device to allow selection of a particular device having a proper fit for an individual patient from an inventory of such devices.
Mouthpieces, mouth guards, and a variety of other oral devices are worn by patients for a variety of purposes. Of particular interest to the present invention, certain oral devices and appliances can be used for treating obstructive sleep apnea (OSA) which is a serious medical condition resulting from temporary airway blockage which occurs as a patient sleeps. A variety of devices have been developed over the years for altering pressure, tongue position, and other characteristics of the oral cavity in order to minimize the occurrence of sleep apnea in patients. One such oral appliance is described in U.S. Pat. No. 8,122,889, assigned to the assignee of the present application, the full disclosure of which is incorporated herein by reference.
Many oral appliances are fitted individually to the patient being treated, typically by taking a full dental impression, forming molds from the impression, and preparing devices which closely conform to the patient's dentition and jaws in order to fit the patient with great accuracy. While such highly accurate fittings may in some cases optimize patient comfort, in all cases they will take time, are inconvenient for the patient, and significantly increase the cost of the oral device.
Thus, for a wide class of oral devices, it will be desirable to provide methods and systems for fitting particular devices from inventories of pre-manufactured devices having different sizes and geometry to individual patients. In some cases, such as with athletic and other mouth guards, the fitting can be rather crude. As described, for example, in U.S. Pat. No. 5,385,155, in some instances it is necessary only to provide devices in three sizes (small, medium, and large) where the devices can be selected using a single sizing template 40 which can be compared to a dental impression plate 44 to determine which of the three sizes best fits the patient.
For more complex devices, such as those intended to treat sleep apnea, more accurate sizing means are desirable, and the ability to rapidly choose from a larger inventory of pre-made devices will be of great benefit. In particular, a system using multiple templates for sizing oral appliances is described in commonly owned U.S. Patent Publication 2012/0037166, the full disclosure of which is incorporated herein by reference. The systems include both a width measuring template for determining the distance between opposed molars and a least one separate arch sizing tool for determining the size and shape of the patient's dental arch. Based on this information, individual appliances can be selected from an inventory of such appliances, where the selected appliance would best fit the patient.
While a great improvement over earlier systems, the sequential use of multiple templates requires multiple steps which can lead to inaccurate measurements. Thus, it would be desirable to provide improved methods and systems for sizing oral appliances that minimize the number of steps required, which are intuitive to use, and which are very accurate. At least some of these objectives will be met by the inventions described hereinafter.
2. Description of the Background Art
U.S. Pat. No. 5,385,155 and U.S. Publication No. 2012/0037166 have been discussed above. U.S. Patent Publ. No. 2009/0120446 describes oral appliances for treating OSA of the type which can be usefully sized by the methods and systems of the present invention.